ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
Location status: Recruiting
NCT Number: NCT06949228
The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2 / Phase 3
Toledo, Ohio, 43606, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control.
Time frame: 90 days (+/- 30 days) post treatment.
Proportion of patients with Modified Rankin Scale (mRS) 0-1 at 90-days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Time frame: 24 hours (+/-12 hours) post treatment.
Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS) associated with a Parenchymal hematoma, Type 2 (PH2) brain hemorrhage, according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria, within 24 (±12) hours from randomization.
Time frame: 90 days (+/-30 days) post treatment.
Ordinal mRS at 90 day. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Time frame: 90 days (+/- 30 days) post treatment.
Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days.
Time frame: Immediate post treatment.
Final revascularization grade at end of IA treatment among those with less than mTICI 3 prior to IA-TNK administration.
Time frame: Mortality rate at 90-days (+/- 30 days) post treatment.
Mortality rate at 90-days
Time frame: Day 6 (+/-1 day) or Discharge post treatment.
Mortality rate at discharge.
Time frame: 24 hours (+/- 12 hours) post treatment.
Infarct volume on post-procedure follow-up scans performed at 24 ± 12 hours following mechanical thrombectomy.
Time frame: 24 hours (+/- 12 hours) post treatment.
Incidence of any asymptomatic intracranial hemorrhage
Time frame: Immediate post procedure.
Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3 among those without mTICI3 prior to IA-TNK administration.
Contact information is provided by the study sponsor or research team.
ProMedica Health System
Other
Acronym: ALLY II TNK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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